Multi-use blood control safety catheter assembly

ABSTRACT

A valve actuator that moves in a catheter assembly between a first position where a valve is closed and a second position where the valve is open, the valve actuator including a shaft portion at a distal end of the valve actuator that is configured to pierce the valve, a mating portion at a proximal end of the valve actuator that is configured to engage a Luer device, a diameter reduction region that connects the shaft portion and the mating portion, and a plurality of windows that extend through the valve actuator for flushing fluid, the plurality of windows being disposed in the diameter reduction region, wherein each of the plurality of windows does not extend a full length of the diameter reduction region.

RELATED APPLICATIONS

This application is a division of U.S. paatent pplication Ser. No.15/567,056 filed on Oct. 16, 2017, which is a U.S. national stageapplication under 35 U.S.C. § 371 of International Application No.PCT/US2016/027955, filed on Apr. 15, 2016, which is acontinuation-in-part of, International Patent Application No.PCT/U2015/026534, filed Apr. 17, 2015, International Patent ApplicationNo. PCT/US2015/026536, filed Apr. 17, 2015, and International PatentApplication No. PCT/US2015/026542, filed Apr. 17, 2015, all of which arehereby incorporated by reference in their entirety.

FIELD

Various exemplary embodiments of the invention relate to catheterassemblies.

BACKGROUND

Catheter assemblies are used to place a catheter properly into thevascular system of a patient. Once in place, catheters such asintravenous catheters may be used to infuse fluids including normalsaline, medicinal compounds, and/or nutritional compositions into apatient in need of such treatment. Catheters additionally enable theremoval of fluids from the circulatory system and monitoring ofconditions within the vascular system of the patient.

SUMMARY OF THE INVENTION

It is an aspect of the present invention to provide a catheter assemblyin which a valve actuator includes a plurality of windows specificallysized and disposed to enhance saline flushing capability. Additionally,a catheter hub includes a floating spring design that improvesmanufacturability and performance. Finally, the catheter hub also usesone of a plurality of materials to reduce magnetic susceptibility in thespring so that the catheter assembly can be used on a patient during amagnetic resonance imaging (MRI) procedure.

The foregoing and/or other aspects of the present invention can beachieved by providing a valve actuator that moves in a catheter assemblybetween a first position where a valve is closed and a second positionwhere the valve is open, the valve actuator comprising a shaft portionat a distal end of the valve actuator that is configured to pierce thevalve, a mating portion at a proximal end of the valve actuator that isconfigured to engage a Luer device, a diameter reduction region thatconnects the shaft portion and the mating portion, and a plurality ofwindows that extend through the valve actuator for flushing fluid, theplurality of windows being disposed in the diameter reduction region,wherein each of the plurality of windows does not extend a full lengthof the diameter reduction region.

The foregoing and/or other aspects of the present invention can furtherbe achieved by providing a valve actuator that moves in a catheterassembly between a first position where a valve is closed and a secondposition where the valve is open, the valve actuator comprising a shaftportion at a distal end of the valve actuator that is configured topierce the valve, a mating portion at a proximal end of the valveactuator that is configured to engage a Luer device, a diameterreduction region that connects the shaft portion and the mating portion,and a plurality of windows that extends through the valve actuator forflushing fluid, wherein the plurality of windows is disposed outside thediameter reduction region.

The foregoing and/or other aspects of the present invention can also beachieved by providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed within the catheter, acatheter hub connected to the catheter having the needle passingtherethrough, the catheter hub including a valve that selectivelypermits or blocks a flow of fluid through the catheter, a valve actuatorthat moves between a first position and a second position, and a returnmember that returns the valve actuator from the second position to thefirst position, and a needle protection member that encloses the sharpdistal tip of the needle, wherein the valve actuator includes a diameterreduction region having a plurality of windows, and each of theplurality of windows does not extend a full length of the diameterreduction region.

The foregoing and/or other aspects of the present invention can also beachieved by providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed within the catheter, acatheter hub connected to the catheter having the needle passingtherethrough, the catheter hub including a valve that selectivelypermits or blocks a flow of fluid through the catheter, a valve actuatorthat moves between a first position and a second position, a returnmember that returns the valve actuator from the second position to thefirst position, and a needle protection member that encloses the sharpdistal tip of the needle, wherein the valve actuator including adiameter reduction region, and a plurality of windows that extendsthrough the valve actuator for flushing fluid, the plurality of windowsbeing disposed outside the diameter reduction region.

The foregoing and/or other aspects of the present invention can also beachieved by providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed within the catheter, acatheter hub connected to the catheter having the needle passingtherethrough, the catheter hub including an inner diameter, a valve thatselectively permits or blocks a flow of fluid through the catheter, avalve actuator that moves between a first position and a secondposition, and a spring that returns the valve actuator from the secondposition to the first position, wherein a clearance fit is providedbetween the spring and the inner diameter.

The foregoing and/or other aspects of the present invention can also beachieved by providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed within the catheter, acatheter hub connected to the catheter having the needle passingtherethrough, the catheter hub including a valve that selectivelypermits or blocks a flow of fluid through the catheter, a valve actuatorthat moves between a first position and a second position, and a returnmember that returns the valve actuator from the second position to thefirst position, and a needle protection member that encloses the sharpdistal tip of the needle, wherein the return member comprises a metallicmember with a magnetic relative permeability of less than 2.0.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and features of the present invention will be moreapparent from the description for the exemplary embodiments of thepresent invention taken with reference to the accompanying drawings, inwhich:

FIG. 1A is a perspective view of an exemplary catheter assembly;

FIG. 1B is an exploded perspective view of the catheter assembly of FIG.1A;

FIG. 2A is a sectional, side view of an exemplary catheter hub andactuator;

FIG. 2B is a perspective view of an exemplary septum;

FIG. 3 is a sectional, side view of an exemplary catheter hub, actuator,and spring with an introducer needle inserted through the catheter hub;

FIG. 4 is a sectional side view of the catheter hub of FIG. 3 with theintroducer needle removed;

FIG. 5 is a sectional, side view of the catheter hub of FIG. 4 with aLuer connector inserted;

FIG. 6 is a sectional, side view of the catheter hub of FIG. 5 with theLuer connector pushing the actuator through the septum;

FIG. 7 is a sectional, side view of the catheter hub of FIG. 6 with theLuer connector being removed;

FIG. 8 is a sectional, side view of the catheter hub of FIG. 7 with theLuer connector removed;

FIG. 9 is a sectional, side view of another exemplary embodiment of acatheter with an actuator and biasing member;

FIG. 10 is a sectional, side view of another exemplary embodiment of acatheter with an actuator and biasing member;

FIG. 11 illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 12 illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 13 illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 14 illustrates a sectional, isometric view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 15A illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 15B is a sectional, side view of the catheter of FIG. 15A with aLuer connector inserted;

FIG. 16 illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 17 illustrates a sectional, perspective view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 18 illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 19A illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 19B is a sectional, side view of the catheter of FIG. 19A pushedthrough the septum;

FIG. 20A illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member;

FIG. 20B is the catheter of FIG. 20A with a Luer connector inserted;

FIG. 21A illustrates a sectional, side view of another exemplaryembodiment of a catheter with an actuator and biasing member and a Luerconnector inserted;

FIG. 21B is a front view depiction of the septum of FIG. 21A;

FIG. 21C is a sectional, side view depiction of the actuator of 21A withan elastomer molded to the tip of the actuator;

FIG. 22 is a perspective view of a side-port catheter;

FIG. 23 illustrates a sectional, side view of an exemplary embodiment ofcatheter with an actuator and a biasing member for a side-port catheter;

FIG. 24 illustrates a sectional, side view of another exemplaryembodiment of catheter with an actuator and a biasing member for aside-port catheter;

FIG. 25 illustrates a sectional, side view of another exemplaryembodiment of catheter with an actuator and a biasing member for aside-port catheter;

FIG. 26 illustrates a sectional, side view of another exemplaryembodiment of catheter with an actuator and a biasing member for aside-port catheter;

FIG. 27 is a sectional, side view of an exemplary catheter assemblyhaving a needle tip shield;

FIG. 28 is a perspective view of an exemplary outer sleeve of the needletip shield;

FIG. 29 is a side view of the outer sleeve of FIG. 28;

FIG. 30 is a top view of the outer sleeve of FIG. 28;

FIG. 31 is a top perspective view of an exemplary inner sleeve of theneedle tip shield;

FIG. 32 is a bottom perspective view of the inner sleeve of FIG. 31;

FIG. 33 is a top perspective view of a needle tip shield clip;

FIG. 34 is a side view of the clip of FIG. 33;

FIG. 35 is a sectional, side view of the needle tip shield of FIG. 27;

FIG. 36 is another sectional, side view of the needle tip shield of FIG.27;

FIG. 37 is a sectional, side view of the needle tip shield with the clipin a closed position;

FIG. 38 illustrates a right side view of another exemplary embodiment ofan actuator;

FIG. 39A illustrates a sectional view of the actuator of FIG. 38 in acatheter hub assembly;

FIG. 39B illustrates a sectional view of the catheter hub assembly ofFIG. 39A when penetrating a septum;

FIG. 39C illustrates a left perspective sectional view of the catheterhub assembly of FIG. 39A when penetrating a septum;

FIG. 40A illustrates a sectional view of another exemplary embodiment ofa catheter hub assembly;

FIG. 40B illustrates a sectional view of the catheter hub assembly ofFIG. 40A when penetrating a septum;

FIG. 40C illustrates a left perspective sectional view of the catheterhub assembly of FIG. 40A when penetrating a septum;

FIG. 41 illustrates a sectional view of another exemplary embodiment ofa catheter assembly in the needle extended position;

FIG. 42 illustrates a sectional view of the catheter assembly of FIG. 41in the needle retracted position;

FIG. 43 illustrates a sectional view of another exemplary embodiment ofa catheter assembly in the needle extended position;

FIG. 44 illustrates a sectional view of the catheter assembly of FIG. 43in the needle retracted position;

FIG. 45 illustrates a sectional view of the catheter hub assembly andthe needle hub assembly of FIG. 44;

FIG. 46 illustrates a sectional view of another exemplary embodiment ofa catheter assembly in the needle extended position;

FIG. 47 illustrates a sectional view of the catheter hub assembly andthe needle hub assembly of FIG. 46 in the needle retracted position;

FIG. 48 illustrates a bottom plan view of the catheter hub assembly andthe needle hub assembly of FIG. 46 in the needle retracted position;

FIG. 49 illustrates an exemplary embodiment of a blood flashback featureof a catheter assembly;

FIG. 50 illustrates a needle in the catheter assembly of FIG. 49;

FIG. 51 illustrates another exemplary embodiment of a blood flashbackfeature of a catheter assembly;

FIG. 52 illustrates a side perspective view of a valve actuatoraccording to a further embodiment including a window in a diameterreduction region;

FIG. 53 illustrates a side perspective view of a valve actuatoraccording to a still further embodiment including a window in a diameterreduction region;

FIG. 54 illustrates a side perspective view of a valve actuatoraccording to a still further embodiment including a window in a diameterreduction region;

FIG. 54A illustrates a cross sectional view of the valve actuator in theembodiment of FIG. 54;

FIG. 55 illustrates a side perspective view of a valve actuatoraccording to a still further embodiment including a window in a diameterreduction region;

FIG. 56 illustrates a side perspective view of a valve actuatoraccording to a still further embodiment including a window outside thediameter reduction region;

FIG. 57 illustrates a side perspective view of a valve actuatoraccording to a still further embodiment including a window outside thediameter reduction region;

FIG. 58 illustrates a rear perspective view of the valve actuator in theembodiment of FIG. 57;

FIG. 59 illustrates an amount of blood remaining on the valve actuatorof FIG. 3 after a saline flush;

FIG. 60 illustrates an amount of blood remaining in the catheter hubwith the valve actuator in the embodiment of FIG. 52 after a salineflush;

FIG. 61 illustrate a graphical comparison of the amount of bloodremaining in the catheter hub with the valve actuators in theembodiments of FIGS. 3 and 53 after a saline flush;

FIG. 62 illustrates a left perspective cross-sectional view of analternate embodiment of the catheter assembly;

FIG. 63 illustrates a left perspective cross-sectional view of thecatheter hub and the needle hub in the embodiment of FIG. 62;

FIG. 64 illustrates a cross-sectional view of the catheter hub in theembodiment of FIG. 62;

FIG. 65 illustrates a cross-sectional view of a valve actuator and aspring in the embodiment of FIG. 62;

FIG. 66 illustrates a perspective view of another embodiment of thevalve actuator;

FIG. 67 illustrates a cross-sectional view of the valve actuator of FIG.66;

FIG. 68 illustrates an enlarged view of a distal end of the valveactuator of FIG. 67;

FIG. 69 illustrates a perspective view of another embodiment of thevalve actuator;

FIG. 70 illustrates a cross-sectional view of the valve actuator of FIG.69; and

FIG. 71 illustrates an enlarged view of a distal end of the valveactuator of FIG. 70.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

A catheter assembly 10, as shown in FIGS. 1A and 1B, includes a hollowintroducer needle 12, a catheter hub 14, and a needle hub 16. Theintroducer needle 12 has a sharpened distal end and extends through thecatheter hub 14. A flexible catheter tube 18 extends from the distal endof the catheter hub 14, with the needle 12 passing through the cathetertube 18. Initially, the needle 12 is inserted into a patient's vein. Thecatheter tube 18 is pushed along the needle 12 and into the veinfollowing the needle 12. After the catheter tube 18 is inserted, theneedle 12 is removed from the patient's vein and the catheter hub 14,leaving the catheter tube 18 in the patient as the needle 12 isdiscarded.

According to various exemplary embodiments, the catheter hub 14 has adistal end 20, a proximal end 22, an inner surface 24, and an outersurface 26. The distal end 20 includes a catheter opening and theproximal end includes a Luer connector opening. The inner surface 24surrounds a channel 28 that permits fluid passage through the catheterhub 14. The outer surface 26 includes one or more projections 30 tosecure a Luer connector 32 (FIG. 4) to the catheter hub 14. Theprojections 30 may form a threaded connection with the Luer connector 32or they may connect to the Luer connector 32 through a snap fit or othertwisting connection. One example of a standard connection is a LUER-LOK®connection. Certain types of Luer connectors 32 utilize a slip fit intothe catheter hub 14. The catheter hub 14 may be made from a polymermaterial that is transparent or semi-transparent so that fluid flowthrough the catheter hub may be observed by a user or it may be madefrom an opaque material.

The flexible catheter tube 18 extends through the catheter opening. Ametal wedge 34 may be positioned in the channel to secure the cathetertube 18 in the catheter opening. The wedge 34 has a first end engagingthe catheter tube 18 and a second end engaging the inner surface 24 ofthe catheter hub 14. The first end of the wedge 34 has a tapered nosethat allows it to easily engage the catheter tube 18. As the wedge 34 isinserted into the catheter tube 18, the catheter tube 18 expands,creating an interference fit between the catheter tube 18, the wedge 34,and the inner surface 24 of the catheter hub 14. The second end of thewedge 34 has a substantially frusto-conical shaped portion with an outeredge that engages the inner surface 24 of the catheter hub 14. A wedgeflange 36 may be formed on the inner surface 24 to create a limit fordistal movement of the wedge 34. A similar shoulder, tab, or groove maylimit the distal movement of the wedge 34.

A pre-slit resilient septum 38 is positioned in the channel 28 andfunctions as a valve that forms a fluid-tight seal and selectivelyadmits fluid to or from the flexible catheter tube 18. In other words,the valve selectively permits or blocks the flow of fluid through theflexible catheter tube 18. The septum 38 may be seated against a septumflange 40 to limit distal movement. Protrusions or other internalstructure may form an interference fit with the septum 38 to retain itin place or limit its proximal movement. As best shown in FIG. 2B, theseptum 38 has one or more pre-formed openings or slits 42 designed toselectively prevent unwanted fluid flow through the septum 38. Theseptum 38 preferably has three intersecting slits 42 forming three flapsthat open when engaged by a valve actuator or a septum actuator(hereinafter actuator).

The septum 38 further includes a plurality of axial flow channels 39.The flow channels 39 are disposed on an outer circumference of theseptum 38. Eight flow channels 39 equidistant from each other areillustrated, although various quantities and positions are contemplated.The flow channels 39 have an appropriate width and depth so that whenthe septum 38 is not opened, blood can enter and air can escape thespace distal of the septum 38 in the front portion of the catheter hub14. At the same time, the flow channels 39 are sized small enough toprevent the blood from exiting past the septum 38 (at least for someperiod of time). Such a configuration is possible because theintermolecular forces in the blood are greater than the intermolecularforces in air.

The septum 38 shown in FIG. 2B may be used in any of the embodimentsdiscussed herein. Other septum configurations may be used as would beunderstood by one of ordinary skill in the art. When the catheter tube18 is initially inserted into a patient, and the introducer needle 12 isremoved, the septum 38 prevents blood from flowing through the channel28 and out of the distal end. The septum 38 is made of an elasticmaterial to form the valve, for example silicone rubber. Other elasticmaterials may be used and non-elastic materials may be incorporated inthe septum 38 as needed.

FIG. 2A depicts an exemplary embodiment of an actuator 44 having anactuator barrel 46 surrounding an internal passage 46A. Actuatorssimilar to that of FIG. 2A may be used in any of the embodimentsdescribed herein. The actuator 44 is positioned in the channel 28 and isaxially moveable in the channel 28 to engage and open the slits 42. Theactuator barrel 46 is a substantially tubular member and the internalpassage 46A is substantially cylindrical to allow fluid to flow throughthe actuator 44 and through the septum 38 when the septum 38 is openedor penetrated by the actuator 44. The tubular member has a distalopening 46B, one or more side openings 46C, and a distal end 46D thatengages and opens the slits 42. The side openings 46C of the actuator 44allow for fluid flushing.

A conical section 48 forms the proximal end of the actuator 44. Theconical section 48 is a substantially frusto-conical member that istapered towards the actuator barrel 46 and has one or more proximalopenings 48A to permit fluid flow. The conical section 48 receives orengages or abuts the end of a Luer connector (not shown). One or moretabs 50 extend from the actuator 44 to engage a respective flange 52 orone or more shoulders on the inner surface 24 of the catheter hub 14.The interaction between the tabs 50 and the flange 52 limits proximalmovement of the actuator 44. The proximal opening 48A and an internalpassage 48B communicating with the internal passage 46A preferably allowfluid to flow between the Luer connector and the catheter tube 18. Sideopenings 48C in the conical section 48 allow for fluid flushing. Theactuator 44 is preferably made in one piece from a rigid or semi-rigidmaterial, for example a rigid polymer material or a metal.

As a male Luer connector is inserted in the catheter hub 14, the end ofthe Luer connector slides toward the conical section 48 and abuts theactuator 44. Further movement of the Luer connector moves the actuator44 axially toward and through the septum 38 with the distal end 46D ofthe actuator barrel 46 separating the one or more slits 42 to engage andopen the septum 38. After the septum 38 is opened by the actuator 44,fluid is permitted to flow from the Luer connector, through the internalpassages 48B and 48D of the actuator 44, and into the flexible catheter18 or vice versa. When the Luer connector 32 is removed, the actuatorbarrel 46 remains in the septum 38.

FIGS. 3-8 depict an embodiment of the catheter assembly 10 that includesa return member 56 which provides a multi-use function for bloodcontrol, for example. The actuator 54 has an actuator barrel 59Asurrounding an internal passage 59B. The actuator barrel 59A is asubstantially tubular member and the internal passage 59B issubstantially cylindrical. The tubular member has one or more openings55 to permit fluid flow through and around the actuator barrel 59A. Theopenings 55 advantageously provide increased area for the fluid to moveinside the catheter hub assembly. The increased area advantageouslyallows for fluid flushing and to prevent coagulation of fluid in theproximal and distal ends of the septum 38. Additionally, the openings 55advantageously minimize the stagnation of fluid and allow for greatermixing.

A first end of the actuator barrel has a nose 58 with a chamfered outersurface to engage the septum 38. A frusto-conical section 61A extendsfrom the second end of the actuator barrel 59A. The frusto-conicalsection 61A has one or more openings 61B to permit fluid flowtherethrough. A cylindrical section 61C extends from the frusto-conicalsection 61A to engage a male Luer connector 32. One or more hooks 60having an angled front surface and a slot 62 extend from the actuatorbarrel 59A.

In the exemplary embodiment shown in FIGS. 3-8, the return member 56 isa biasing member such as a coil spring, for example a helicalcompression spring with a distal end 64 and a proximal end 66. Thespring can be, but is not limited to, rubber, silicone rubber, a thermalplastic, a thermal plastic elastomer, metal, plastic, an elastomericmember such as an elastomer, or another suitable resilient material. Thedistal end 64 of the spring forms an interference fit with the innersurface 24 of the catheter hub 14. The interference fit may besufficient to retain the spring, even during loading, or the distal end64 of the spring may also abut the septum 38. The proximal end 66 of thespring connects to the actuator 54, for example by fitting over the hook60 and into the slot 62.

In other various embodiments, the actuator 54 and the biasing member 56are combined to be a unitary structure. In various exemplaryembodiments, the inner surface 24 of the catheter hub 14 and/or theouter surface of the actuator 54 and/or biasing member 56 includesundercuts, bumps, projections, tines, or other suitable structure toform a snap connection between the catheter hub 14 and the biasingmember 56, and the biasing member 56 and the actuator 54. In furthervarious exemplary embodiments, the biasing member or spring 56 andactuator 54 may be attached to each other via an engagement that doesnot require a snap connection including a diametric interference fit ora press fit.

FIGS. 3-7 depict the operation of the catheter hub 14 having an actuator54 and a return member such as a biasing member or spring 56. The returnmember functions by returning the actuator 54 from a second positionengaging the septum 38 (opening or penetrating the septum, for example)to open the valve, to a first position at a proximal end of the septum38 (not engaging the septum 38) to close the valve. The needle 12initially extends through the actuator 54, the septum 38, the wedge 34,and the catheter tube 18. After the needle 12 and the catheter tube 18are inserted into a patient, the needle 12 is withdrawn, closing theseptum 38.

There are two basic ways to open the septum 38, either of which can beused in the practice of the present invention. In the first way, theseptum 38 can be in an opened state when the actuator 44 contacts orpushes against the slits 42 of the septum 38. When the septum 38 isopened in this way, the actuator 44 does not extend through the septum38. Rather, the end surface of the actuator 44 is disposed on the slits42 of the septum 38. Either the resilient slits 42 or flaps of theseptum 38, or the spring 56, or both, can cause the actuator 44 toretract when operation is complete and upon removal of the axialpressure on the actuator 44. In the second way, the septum 38 can be ina penetrated state where the actuator 44 extends through the septum 38causing the septum 38 to open. In this state, the actuator 44 requiresan external force, such as the spring 56, to retract the actuator 44 andclose the septum 38. In the penetrated state, the resilient slits 42 ofthe septum 38 cannot retract the actuator 44 on their own. Both septumstates can open the septum 38 and allow fluid to be exchanged.

As shown in FIGS. 5 and 6, as the male Luer connector 32 is insertedinto the catheter hub 14, the Luer connector 32 moves the actuator 54 inthe distal direction, compressing the spring 56. Further insertion ofthe Luer connector 32 moves the actuator 54 through the septum 38,opening the slits 42 and allowing fluid to flow through the catheter hub14. As best shown in FIGS. 7 and 8, when the Luer connector 32 isremoved, the spring 56 removes the actuator 54 from the septum 38,closing the slits 42 and preventing fluid from flowing therethrough.This allows the catheter assembly 10 to be reused through multiple Luerconnections, as opposed to a single use catheter where the actuatorwould remain in the septum 38 after a Luer connector is removed. Thefeatures of the exemplary embodiments of FIGS. 3-8 may be combined withfeatures of the other exemplary embodiments disclosed herein asappropriate.

Although the return member 56 is shown as a biasing member (e.g. springor other resilient member) in all of the embodiments disclosed herein,the invention is not so limited. The return member may be any element orassembly that returns the actuator from its second position to its firstposition when a Luer connector is removed. When constituted as a biasingmember, the return member 56 can be, but is not limited to, rubber,silicone rubber, a thermal plastic, or a thermal plastic elastomer. Thereturn member 56 can also be constituted by the resilient slits 42 orflaps of the septum 38, as discussed above.

FIG. 9 depicts an alternative embodiment of the actuator 68 and thebiasing member 70A. The actuator 68 has an actuator barrel 69Asurrounding an internal passage 69B. The actuator barrel 69A is asubstantially tubular member and the internal passage 69B issubstantially cylindrical. A series of openings 69C are formed in theactuator barrel 69A to allow fluid to flow through and around theactuator 68. The actuator barrel 69A has a distal end 69D that engagesand opens the septum 38. The distal end 69D includes a nose having achamfered outer surface. A conical section 71A extends from the proximalend 71B of the actuator barrel 69A. The conical section 71A is asubstantially frusto-conical member receives or engages the end of aLuer connector.

The biasing member is a helical metal compression spring 70A with adistal end 70B and a proximal end 70C. The distal end 70B of the spring70A has a first outer diameter and a first inner diameter. The proximalend 71B of the spring 70A has a second outer diameter and a second innerdiameter. The second outer diameter may be different from the firstouter diameter and the second inner diameter may be different from thefirst inner diameter. The spring 70A may have a general conical shape.

In various exemplary embodiments, the first outer diameter is sized tocreate a first interference fit with the inner surface of the catheterhub 14. The first interference fit may be sufficient to allowcompression of the spring 70A without contact between the spring 70A andthe septum 38. In alternative embodiments, the septum 38 may assist inlimiting the axial movement of the spring 70A. The second inner diameteris sized to create a second interference fit with the actuator 68, forexample the actuator barrel 69A. The second interference fit issufficient to retain and support the actuator 68 in place in anunstressed condition, both axially and radially, with respect to thecatheter hub 14. The second interference fit may be sufficient to allowcompression of the spring 70A without contact between the spring 70A andthe catheter hub 14. Because of the support provided by the spring 70A,the actuator 68 is held, substantially self-centered and does not touchthe inside walls of the catheter hub 14 as shown. The spring 70Aretaining the actuator 68 in the catheter hub 14 provides an advantageover the catheter shown in FIG. 2, because the actuator tabs 50 and thecorresponding shoulder 52 extending from the inner surface are removed.Removal of the tabs 50 and shoulder 52 reduces complexity of the device.In various alternative embodiments, the tabs 50 are used to retain theactuator and the spring 70A is freely positioned in the catheter hub 14without an interference fit with the catheter hub 14 or the actuator 68.

In accordance with the illustrated embodiment, the spring's first outerand inner diameters are greater than the second outer and innerdiameters. The pitch of the spring 70A also varies from the distal endto the proximal end. The spring 70A may have one or more coils that aretouching or very closely positioned at the distal end and one or morecoils that are touching or very closely positioned at the proximal endin an unloaded state. The variable pitch of the spring 70A allowsstiffness to be concentrated at the distal and proximal ends to assistin retaining the interference fit while also allowing for sufficientcompression through the middle of the spring 70A. The features of theexemplary actuator 68 and biasing member 70A depicted in FIG. 10 may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

As a Luer connector (not shown) is inserted in the catheter hub 14, theend of the Luer connector abuts the conical section of the actuator 68.Further movement of the Luer connector moves the actuator 68 axiallytoward and through the septum 38 with the first end of the actuatorbarrel separating the one or more slits. Movement of the actuator 68toward the septum 38 compresses the spring 70A. After the septum 38 isopened, fluid is permitted to flow through the catheter hub 14. Thecompression of the spring 70A is maintained by the Luer connector. Asthe Luer connector is removed, the spring 70A returns the actuator toits initial position, removing the actuator 68 from the septum 38. Afterthe actuator 68 is removed, the septum 38 returns to the closedposition, preventing fluid from flowing therethrough. The features ofthe exemplary embodiments of FIG. 9 may be combined with features of theother exemplary embodiments disclosed herein as appropriate.

FIG. 10 depicts another alternative embodiment of a catheter hub 14having an actuator 72 and a return or biasing member 74. The actuator 72has an actuator barrel 73A surrounding an internal passage. The actuatorbarrel 73A is a tubular member surrounding a cylindrical internalpassage. A series of openings 73B are formed in the tubular member toallow fluid to flow through and around the actuator 72. The actuatorbarrel 73A has a first end 75A that engages and opens the slits of theseptum 38. The first end 75A includes a nose having a chamfered outersurface. A cylindrical section 75C extends from the second end 75B ofthe tubular portion. The cylindrical section 75C may have a conicalaperture for receiving a Luer connector or the aperture may be acontinuation of the cylindrical internal passage.

The return or biasing member in FIG. 10 is a helical metal compressionspring 74 with a distal end and a proximal end. The distal end isinterference fit with the inner surface of the catheter hub 14 and theproximal end is interference fit with the actuator 72. The inner surfacemay have a channel, groove, slot, or other depression 76 to receive thedistal end of the spring 74. The spring 74 depicted in FIG. 10 may besimilar to, or the same as, the spring 70A depicted in FIG. 9.

As discussed above, the conical spring 74 supports the actuator end andthereby allows for removal of the actuator tabs 50. The catheter 10 isdesigned for use with different sized Luer connectors that penetrate theinterior channel at different lengths. Because the tabs 50 of theexemplary actuator 44 depicted in FIG. 2 cannot travel through theseptum 38, the length of the tubular portion is increased to accommodatethe different sized Luer connectors. As best shown in the exemplaryembodiment of FIG. 10, by removing the tabs 50, the actuator 72 and thecatheter hub 14 can be shortened, reducing the size and the cost of thedevice. The features of the exemplary embodiments of FIG. 10 may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

FIG. 11 depicts another alternative embodiment of a catheter hub 14having an actuator 78 and a return or biasing member 80. The actuator 78has an actuator barrel surrounding an internal passage. The actuatorbarrel and the internal passage have a conical shape tapering from theproximal end to the distal end of the catheter hub. The actuator barrelhas a first end that engages and opens the slits 42. The first endincludes a nose having a chamfered outer surface. One or moreprotrusions 82 extend radially from the barrel to engage the biasingmember 80. The protrusions 82 may be a single, frusto-conical flangeextending around the outer surface of the barrel, one or more tabsextending from the barrel, or other similar structure.

The biasing member 80 in FIG. 11 is preferably an elastomer springhaving an outer surface engaging the inner surface of the catheter hub14 and an aperture receiving at least a portion of the actuator 78. Thebiasing member 80 can also be, but is not limited to, rubber, siliconerubber, a thermal plastic, or a thermal plastic elastomer. In accordancewith an exemplary embodiment, the aperture includes a proximal opening84, a middle opening 86, and a distal opening 88. The proximal opening84 has a substantially cylindrical shape with a first diameter. Themiddle opening 86 has a second diameter larger than the first diameter.The middle opening 86 may cylindrical or it may be bound by one or moreangled walls to having a substantially frusto-conical shape. Forexample, the middle opening 86 may be bound by walls having an anglethat corresponds to the angle of the actuator protrusions 82. The distalopening 88 has a substantially cylindrical shape and diameter that issmaller than the diameter of the proximal opening 84 and a diametersmaller than the middle opening 86. In various exemplary embodiments,the size, shape, and configuration of the elastomer spring and theopenings may vary depending on the catheter hub 14 and the actuator 78.

The actuator 78 is placed into the elastomer spring 80 so that at leasta portion of the first end of the actuator barrel extends through andprotrudes from the elastomer spring 80. The actuators protrusions 82 sitin the middle opening 86 to retain the actuator 78 in place and resistproximal movement of the actuator 78. The second end of the actuatorextends from the proximal opening 84 to receive or engage a male Luerconnector (not shown). As a Luer connector is inserted, the actuator 78is moved in the distal direction against the bias of the elastomerspring 80, elastically deforming the elastomer spring 80. As the Luerconnector is removed, the elastomer spring 80 returns the actuator 78substantially to its initial position. The features of the exemplaryactuator and biasing member depicted in FIG. 11 may be combined withfeatures of the other exemplary embodiments disclosed herein.

FIG. 12 depicts another alternative embodiment of a catheter hub 14having an actuator 90 and a return or biasing member 92. A first end ofthe actuator 90 has an actuator barrel surrounding an internal passage.The actuator barrel has a substantially frusto-conical shape taperingfrom the distal end to the proximal end of the catheter hub. Theactuator barrel has one or more openings permitting fluid flow throughthe actuator. The actuator 90 includes a second end for receiving orengaging a Luer connector. The second end has a substantiallyfrusto-conical shape. The second end may also include one or moreopenings and an internal passage. A middle portion 94 connects the firstend and the second end of the actuator 90. The middle portion 94 has asubstantial cylindrical shape surrounding an internal passage.

The biasing member 92 in FIG. 12 is preferably an elastic washer. Thewasher 92 has an outer surface that engages the inner surface of thecatheter hub 14. The inner surface of the catheter hub may include aslot or groove 96 to receive and retain the washer 92. The washer 92 hasan inner diameter that receives the middle portion 94 of the actuator90. The middle portion 94 may have a diameter that is smaller than thefrustum of the second end and smaller than the base of the first end,retaining the washer against a first flange formed by the first end anda second flange formed by the second end. The shape, size, andconfiguration of the actuator 90 and the washer 92 may vary toaccommodate one another.

The actuator 90 is placed into the washer 92 so that the first end ofthe actuator 90 extends through and protrudes from one side of thewasher 92 to engage the septum 38. The second end of the actuator 90extends from the washer 92 to receive or engage a male Luer connector32. As the Luer connector 32 is inserted, the actuator 90 is moved inthe distal direction against the bias of the washer 92, elasticallystretching the washer 92. Further insertion of the Luer connector 32moves the actuator 90 through the septum 38, opening the slits 42. Asthe Luer connector 32 is removed, the washer 92 returns the actuator 90to its initial position. In various additional embodiments, the washer92 can be, but is not limited to, rubber, silicone rubber, a thermalplastic, a thermal plastic elastomer, a spring washer, an elastomericwasher, a plurality of elastic bands, a compression spring, an extensionspring, a disc spring, or other suitable biasing member. The features ofthe exemplary actuator 90 and biasing member 92 depicted in FIG. 12 maybe combined with features of the other exemplary embodiments disclosedherein as appropriate.

FIG. 13 depicts another alternative embodiment of a catheter hub 14having an actuator 98 and a return or biasing member 100. The actuator98 has an actuator barrel surrounding an internal passage. The actuatorbarrel has a first end that engages and opens the slits 42. The actuator98 includes a second end for receiving or engaging a male Luer connector(not shown).

The biasing member in FIG. 13 can be, but not limited to, one or moreelastic members 100, for example, a circular or radially extendingsilicone member, a plurality of elastic bands, rubber, silicone rubber,a thermal plastic, or a thermal plastic elastomer. In various exemplaryembodiments, the elastic bands are made from silicone or siliconerubber. The biasing member 100 is connected to a fixed support 102attached to the inner surface of the catheter hub 14. The fixed supportmay be a single member extending radially around the inner surface or itmay be one or more isolated blocks depending on the type of biasingmember.

The biasing member 100 receives and/or connects to the actuator 98 toretain the actuator 98 in an unstressed position. As a male Luerconnector is inserted, the actuator 98 is moved in the distal directionstretching the biasing member 100. As the Luer connector is removed, thebiasing member 100 returns the actuator 98 to its initial position. Thefeatures of the exemplary actuator 98 and biasing member 100 depicted inFIG. 13 may be combined with features of the other exemplary embodimentdisclosed herein as appropriate.

FIG. 14 depicts another alternative embodiment of a catheter hub 14having an actuator 104 and a return or biasing member 106. The biasingmember 106 is similar to those discussed above with respect to FIG. 13.The actuator has an actuator barrel surrounding an internal passage. Theactuator barrel has a first end that engages and opens the slits 42. Theactuator includes a second end for receiving or engaging a Luerconnector (not shown). The actuator barrel and catheter hub 14 areshorter than those depicted in other embodiments, although any of theactuators or catheter hubs described herein may be used with thisembodiment. The biasing member 106 may be, but is not limited to,rubber, silicone rubber, a thermal plastic, a thermal plastic elastomer,one or more bands, a radially extending member, or other suitablebiasing member. The biasing member 106 includes a flange 108 that fitsinto a groove or slot in the catheter hub 14. The features of theexemplary actuator 104 and biasing member 106 depicted in FIG. 14 may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

FIGS. 15A-15B depicts another alternative embodiment of a catheter hub14 having an actuator 110 and a return or biasing member 112. Theactuator 110 has an actuator barrel surrounding an internal passage. Theactuator barrel has a first end that engages and opens the slits 42. Thefirst end includes a nose having a chamfered outer surface. The secondend of the actuator barrel receives or engages a male Luer connector 32.

The biasing member is an elastic band or disk 112 that is connected nearthe second end of the actuator 110. The elastic band 112 may be madefrom, but is not limited to, latex, rubber, silicone rubber, a thermalplastic, a thermal plastic elastomer, or other suitable elasticmaterial. A first end of the elastic band 112 is connected to thecatheter hub 14. A second end of the elastic band 112 is connected tothe actuator 110, for example by an interference fit, or othermechanical connection, or through a chemical bond such as an adhesive ormolded bond. The features of the exemplary actuator 110 and biasingmember 112 depicted in FIGS. 15A-B may be combined with features of theother exemplary embodiments disclosed herein as appropriate.

FIG. 16 depicts another alternative embodiment of a catheter hub 14having an actuator 114 and a return member comprising a first biasingmember 116 and a second biasing member 118. The actuator 114 has anactuator barrel surrounding an internal passage. The actuator barrel hasa first end that engages and opens the slits 42. The first end includesa nose having a chamfered outer surface. Extending from the second endof the actuator barrel is a cylindrical member for receiving or engaginga Luer connector (not shown). A compressible section 120 is positionedin the actuator barrel. The compressible section 120 is made from asuitable compressible material, for example an elastomer or a polymer.

Similar to the biasing members depicted in FIGS. 13-15B, the first andsecond biasing members 116, 118 of FIG. 16 may be one or more bands ofelastic material, a radially extending member, or other suitable biasingmember. In various additional embodiments, the biasing members depictedin FIGS. 13-16 may be, but are not limited to, a spring washer, anelastomeric washer, a plurality of elastic bands, a compression spring,an extension spring, a disc spring, rubber, silicone rubber, a thermalplastic, a thermal plastic elastomer or other suitable biasing member.The first and second biasing members 116, 118 are connected to thecatheter hub 14 through one or more support blocks 122. In variousexemplary embodiments, only a single biasing member is used.

As a Luer connector is inserted, the Luer connector engages thecompressible insert 120 and moves the actuator 114 in the distaldirection against the bias of the first and second biasing members 116,118. Further insertion of the Luer connector moves the actuator throughthe septum (not shown), opening the slits 42. The first and secondbiasing member 116, 118 and the compressible insert 120 are configuredso that the actuator 114 may advance a certain distance until theresilient force of the biasing members 116, 118 is greater than theforce needed to compress the insert 120. At this point, the insert 120deforms so that further insertion of the Luer connector does not resultin further distal movement of the actuator 114. As the Luer connector isremoved, the insert 120 expands to its normal volume and the first andsecond biasing members 116, 118 return the actuator 114 to its initialposition. The features of the exemplary actuator 114 and biasing members116, 118 depicted in FIG. 16 may be combined with features of the otherexemplary embodiments disclosed herein.

FIG. 17 depicts another alternative embodiment of a catheter hub 14having an actuator 122 and a return or biasing member 124. The actuator122 has an actuator barrel surrounding an internal passage. The actuatorbarrel has a first end that engages and opens the slits 42. Extendingfrom the second end of the actuator barrel is a member (not shown) forreceiving or engaging a Luer connector. One or more protrusions 126extend from the actuator radially towards the inner surface of thecatheter hub 14. The protrusions 126 engage tabs (not shown) on thecatheter hub 14 to limit the axial movement of the actuator 122, similarto the embodiment depicted in FIG. 2.

The biasing member 124 of FIG. 17 extends from the septum 128 in thedistal direction. The biasing member 124 includes two or more arms 130connected to a central hub 132. The central hub 132 is shown as acylindrical member having an opening. The central hub 132 is configuredto engage at least a portion of a front end of the actuator 122. Varioussizes, shapes, and configurations of the central hub 132 may be useddepending on the catheter hub 14 and the actuator 122. The biasingmember 124 is preferably made from an elastic material, for example asilicone rubber. The biasing member 124 can also be made from, but isnot limited to, rubber, silicone rubber, a thermal plastic, or a thermalplastic elastomer. The septum 128 and the biasing member 124 may beunitarily formed or the septum 128 and/or slits 42 may be formedseparately from the biasing member.

In various exemplary embodiments, the septum 38 is configured to returnthe actuator to its initial position. As a male Luer connector (notshown) is inserted, the actuator 122 is moved in the distal direction,opening the slits 42 and passing through the septum 128. The septum 38includes one or more slits 134 with the slits 134 defining two or moreflaps. In the exemplary embodiment illustrated in FIG. 17, the septum 38has three slits 134 defining three triangular flaps. As the actuator 122is inserted into the septum 38, the flaps move in the distal directionto receive the actuator 122. The flaps are resilient and exert a biasingforce on the actuator 122, which may be sufficient, depending on thedepth of insertion of the actuator 122, to return the actuator 122substantially to its initial position or at least to a position thatallows the slits 42 to close.

As mentioned above, the length of a Luer connector varies, and the depthof penetration of the Luer connector into the catheter hub 14 and theresulting movement of the actuator 122 varies depending on the Luerconnector. At a certain travel distance of the actuator 122 through theseptum 38, the septum 38 is not capable of returning the actuator 122 toa position that allows the slits 42 to close. In accordance with theexemplary embodiment, the biasing member 124 is configured to bias theactuator 122 at least to a point where the slits 42 can move theactuator 122 to a position that allows the septum 38 to close. If thepenetration of the Luer connector is long enough, the first end of theactuator 122 moves through the septum 38 and engages the biasing member124, for example the central hub 132. Further movement of the actuator122 stretches the arms 130. As the Luer connector is removed, thebiasing member 124 moves the actuator 122 in the proximal directionuntil the biasing member 124 is in an unstressed state. At this point,the septum 38 moves the actuator 122 in the proximal direction asufficient distance to allow the slits 42 to close. The features of theexemplary actuator 122 and biasing member 124 depicted in FIG. 17 may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

FIG. 18 depicts another alternative embodiment of a catheter hub 14having an actuator 134 and a return or biasing member 136. The actuator134 has an actuator barrel surrounding an internal passage. The actuatorbarrel has a first end that engages and opens a septum 38. The first endincludes a nose having a chamfered outer surface. The second end of theactuator barrel receives or engages a Luer connector (not shown). A pin138 extends radially from the side of the actuator barrel. The pin 138mates with a slot 140 formed in the catheter hub 14. In an exemplaryembodiment, the slot 140 is a cam slot that has a first portionextending substantially in an axial direction of the catheter hub 14 anda second portion extending obliquely, axially in the distal directionand radially upwards, from the first portion.

The biasing member 136 of FIG. 18 can be, but is not limited to, rubber,silicone rubber, a thermal plastic, a thermal plastic elastomer, aspring, leaf spring, an elastic band, or other resilient member. Thebiasing member 136 may exert a force on the actuator 134 in both theaxial and radial directions or only in the radial direction. In anexemplary embodiment, the majority of the force exerted by the biasingmember 136 is in the radial direction. As the Luer connector is insertedinto the catheter hub 14, the Luer connector moves the actuator 134 inthe distal direction. Movement of the actuator 134 causes the pin 138 toslide in the cam slot 140, forcing the actuator 134 to move radially aswell as axially. As the Luer connector is removed, the biasing member136 forces the actuator back down, moving the pin 138 along the cam slot140 to its initial position. In various exemplary embodiments, thebiasing member 136 may only act in the radial direction, for exampleradially downward in the depicted orientation, with sufficient force toslide the pin 138 along the cam slot 140 to the initial position. Thefeatures of the exemplary actuator 134 and biasing member 136 depictedin FIG. 18 may be combined with features of the other exemplaryembodiments disclosed herein as appropriate.

FIGS. 19A-19B depict another alternative embodiment of a catheter hub 14wherein the actuator and the return or biasing member are constituted bya single spring 142. The spring 142 has a first series of windings 144that extend in the axial direction. The first series of windings 144have a first end that extends through the septum 38. The first series ofwindings 144 may have a first inner diameter at a distal end and asecond inner diameter larger than the first inner diameter at a proximalend. A second series of windings 146 extend around at least a portion ofthe first series of windings 144. The second series of windings 146 maybe coaxial with the first series of windings 144 and have a first innerdiameter at a proximal end and a second inner diameter greater than thefirst inner diameter at a distal end. The second series of windings 146has at least one coil that forms an interference fit with the catheterhub 14. The catheter hub 14 may have a shoulder extending around theinner surface to limit movement of the first and second windings 144,146.

As a male Luer connector is inserted, the first series of windings 144are moved in the distal direction, compressing the second series ofwindings 146. Further insertion of the Luer connector moves the firstset of windings 144 through the septum 38, opening the slits 42. As theLuer connector is removed, the second set of windings 146 return thefirst set of windings 144 to their initial position. The features of theexemplary actuator and biasing member 142 depicted in FIGS. 19A-19B maybe combined with features of the other exemplary embodiments disclosedherein as appropriate.

FIGS. 20A-20B depict another alternative embodiment of a catheter hub 14having an actuator 148 and a return or biasing member 150. The actuator148 has an actuator barrel surrounding an internal passage. The actuatorbarrel has a first end that engages and opens the slits 42. The firstend includes a rounded nose. A flange 152 for engaging the Luerconnector 32 extends from the second end of the actuator barrel. Theflange 152 is positioned in a slot 154 formed in the catheter hub. Theengagement of the flange 152 with the slot 154 limits the axial movementof the actuator.

The biasing member in FIGS. 20A-20B is preferably an elastomer tube 150that is positioned around the actuator barrel. However, the biasingmember can also be, but is not limited to, rubber, silicone rubber, athermal plastic, or a thermal plastic elastomer. In various exemplaryembodiments, the elastomer tube 150 is molded to the actuator 148, forexample in a multi-shot molding process, although other suitablemechanical and chemical connections may be used. The elastomer tube 150has one or more slits 151 that open to allow passage of the actuatortherethrough.

As a male Luer connector 32 is inserted, the actuator 148 is moved inthe distal direction so that the elastomer tube 150 engages the septum38. Further insertion of the Luer connector 32 causes the actuatorbarrel to pass through the slits in the elastomer tube 150 and compressthe elastomer tube 150 as the actuator 148 moves through the septum 38.As the Luer connector 32 is removed, the elastomer tube 150 returns theactuator 148 to its initial position. In various exemplary embodiments,the septum 38 may assist in moving the actuator 148 in the proximaldirection. The features of the exemplary actuator 148 and biasing member150 depicted in FIGS. 20A-B may be combined with any features of theother exemplary embodiments disclosed herein as appropriate.

FIGS. 21A-21C depict another alternative embodiment of a catheter hub 14having an actuator 152 and a return or biasing member 154. The actuator152 has an actuator barrel surrounding an internal passage. The actuatorbarrel has a first end that engages and opens the slits 42. Extendingfrom the second end of the actuator barrel is a cylindrical member forengaging the male Luer connector 32. The actuator is made from a rigidor semi-rigid material.

The biasing member of FIGS. 21A-21C preferably includes a compressibleelastic sleeve 154. However, the biasing member can also be, but is notlimited to, rubber, silicone rubber, a thermal plastic, or a thermalplastic elastomer. In various exemplary embodiments, the elastic sleeve154 is unitarily formed with the septum 156. In a further embodiment,the septum 156 and biasing member 154 are unitarily formed with theactuator 152, for example by a multi-shot molding process thatover-molds the septum 156 and biasing member 154 onto the actuator. Inother alternative embodiments, the septum 156 and biasing member 154 maybe connected, wrapped, or held together by an interference fit, forexample with the cylindrical member pressing a portion of the elasticsleeve 154 against the inner surface of the catheter hub 14. The septum156 and elastic sleeve 154 include a silicone material though othersuitable materials may be used.

As best shown in FIG. 21B, the septum 156 has an oval configuration andis formed with a single slit 158. The slit 158 may be formed duringmolding or cut into the septum 156 after the molding operation. Theseptum 156 is configured so that the slit is in an open orientation inan unstressed condition. The septum 156 is fit into a slot or groove inthe inner surface of the catheter hub 14. The groove is sized tocompress the slit into a closed orientation, forming a fluid tight seal.As best shown in FIG. 21C, an elastomer 160 may be over-molded orassembled on the front edge of the conductor.

As a male Luer connector 32 is inserted, the actuator is moved in thedistal direction, compressing the sleeve 154. Further insertion of theLuer connector 32 moves the actuator 152 through the septum 156, openingthe slits 42. As the Luer connector 32 is removed, the sleeve 154returns the actuator 152 to its initial position. The septum 38 may alsoassist in moving the actuator 152 in the proximal direction. Thefeatures of the exemplary actuator 152 and biasing member 154 depictedin FIGS. 21A-21C may be combined with features of the other exemplaryembodiments disclosed herein as appropriate.

FIG. 22 depicts a side-port catheter hub 162 and FIGS. 23-26 depictvarious exemplary embodiments of an actuator 164 and a return or biasingmember 166 used with a side-port catheter hub 162. The catheter hub 162includes a channel and a side port 168 extending substantiallyorthogonal to the channel. A septum 170 forming a first valve ispositioned in the channel. A side valve, for example a valve sleeve 172,is also positioned in the channel to form a second valve for the sideport 168. The valve sleeve is an elastic member, for example a length ofsilicone or rubber tubing. The valve sleeve 172 is compression fit inthe catheter hub. When fluid is introduced into the side port 168, thevalve sleeve 172 deforms in the radial direction, permitting fluid toflow around the valve sleeve 172 and into the channel. Reference is madeto U.S. Pat. No. 4,231,367, incorporated by reference herein, for a sideport catheter with a valve sleeve of the type described herein.

FIGS. 23-26 depict an actuator 164 having an actuator barrel surroundingan internal passage. The actuator barrel has a first end that engagesand opens the valve. A cylindrical or frusto-conical member extends fromthe second end of the actuator barrel to engage a male Luer connector.The biasing member 166 is depicted as a metal spring. However, thebiasing member 166 can also be, but is not limited to, rubber, siliconerubber, a thermal plastic, or a thermal plastic elastomer.

In the exemplary configuration of FIG. 23, the septum 170 is positionedin catheter hub 162 distal to the side valve 172 and the biasing member166 is positioned in the catheter hub 162 proximal to the side valve172. The biasing member 166 is connected at a first end to the innersurface of the catheter hub 162 and at a second end to the actuator 164,for example by a pair of interference fits. The biasing member 160 mayalso abut the side valve 172 to limit distal movement.

In the exemplary configuration of FIG. 24, the septum 170 and thebiasing member 166 are positioned distal to the side valve 172. Thebiasing member 166 is connected at a first end to the inner surface ofthe catheter hub 162 and at a second end to the actuator 164, forexample by a pair of interference fits. The actuator 164 includes aflange 174 or one or more tabs extending radially from the actuatorbarrel to receive or abut the second end of the biasing member 166.

In the exemplary configuration of FIG. 25, the septum 170 and thebiasing member 166 are positioned proximal to the side valve 172. Thebiasing member 166 is connected at a first end to the inner surface ofthe catheter hub 162 and at a second end to the actuator 164, forexample by a pair of interference fits. The biasing member may also abutthe septum 170 to limit distal movement.

In the exemplary configuration of FIG. 26, the septum 170 and the sidevalve 172 are unitarily formed. The biasing member 166 is connected at afirst end to the inner surface of the catheter hub 162 and at a secondend to the actuator 164, for example by a pair of interference fits. Thebiasing member 166 may also abut the side valve 172 to limit distalmovement. The features of the exemplary actuator and biasing memberdepicted in FIGS. 22-26 may be combined with features of the otherexemplary embodiments disclosed herein as appropriate.

Any of the catheters described herein can be used in combination withthe features as depicted in FIGS. 27-37. The needle hub 14 extendsaround a needle tip shield 176 and retains a proximal end of a needle12. A needle cover 178 initially covers the needle 12, the catheter tube18, and at least a portion of the catheter hub 14. The needle cover 178can connect to the catheter hub 14 or to the needle hub 16. The needle12 initially extends through the needle tip shield 176 and the catheterhub 14. The flexible catheter tube 18 extends from the distal end of thecatheter hub 14, with the needle 12 passing through the catheter tube18. Initially, the needle 12 is inserted into a patient's vein. Thecatheter tube 18 is pushed along the needle 12 and into the veinfollowing the needle 12. After the catheter tube 18 is inserted, theneedle 12 is removed from the patient's vein and through the catheterhub 14. The needle tip shield 176 provides protection from being stuckby the needle 12 as it is retracted from the catheter hub.

In accordance with the exemplary embodiments depicted in FIGS. 27-36,the needle tip shield 176 includes an outer sleeve 178, an inner sleeve180, and a resilient metal clip 182. The outer sleeve 178 connects tothe catheter hub 14 and surrounds the inner sleeve 180, and the clip182. The inner sleeve 180 is positioned in the outer sleeve 178 and ismoveable in the axial direction. The clip 182 is connected to, andaxially moveable with, the inner sleeve 180.

In accordance with the exemplary embodiments depicted in FIGS. 28-30,the outer sleeve 178 includes an outer surface 184, an inner surface186, a channel bound by the inner surface 186, a proximal opening, and adistal opening. The outer surface 184 has an octagonal configurationwith eight planar sides, although other curvilinear and/or rectilinearshapes may be used. The inner surface 186 has a planar top wall and aplanar bottom wall connected by a pair of curved sides. A slot 188extends through a wall of the outer sleeve 178.

A catch 190 extends from the outer surface to engage a protrusion on thecatheter hub 14. In the exemplary embodiment, the catheter hubprotrusion is a Luer connector receiving thread, for example a LUER-LOK®style of thread. The catch 190 has a front edge, a back edge, and a pairof side edges. An opening or depression is formed between the front edgeand the back edge to receive the catheter hub protrusion. The openingallows the catch 190 to be formed with a clearance approximately equalto, or slightly greater than the height of the projection, allowing thecatch 190 to engage the front, back, and/or sides of the connectionwhile minimizing the amount of material and space needed. In variousexemplary embodiments, the catch 190 is formed without the opening. Thecatch 190 resists premature release of the needle tip shield 176 fromthe catheter hub 14.

In accordance with the exemplary embodiments depicted in FIGS. 31 and32, the inner sleeve 180 includes a base 192, a distal side 194, and aproximal side 196. A resilient arm 198 and a tab 200 extend from anouter surface of the base 192. The resilient arm 198 and the tab 200engage the slot 188 in the outer sleeve 184. One or more clip retainers202 extend from an inner surface of the base 192. The clip is positionedbetween the clip retainers 202 and the proximal side 196. An opposingmember 204 extends from the distal side 194 in the distal direction. Theopposing member 204 is tubular and configured to be inserted into thecatheter hub 14. The proximal side 194, distal side 196, and opposingmember 204 each have an opening for receiving the needle 12.

In accordance with the exemplary embodiments depicted in FIGS. 33 and34, the resilient metal clip 182 includes a base 206 having an openingfor receiving the needle 12, a first arm 208, and a second arm 210extending from the base 206. The first arm 208 extends further in theaxial direction than the second arm 210. The first arm 208 has a firsthook 212 and the second arm 210 has a second hook 214. A first tab 218is formed in the first arm 208 and a second tab 220 is formed in thesecond arm 210.

Initially, the needle 12 passes through the outer sleeve 178, the innersleeve 178, and the clip 182. The needle 12 biases the clip 182 into anopen position, so that the first and second hooks 212, 214 are restingalong the needle shaft. In the assembled position, the catch 190 engagesthe Luer threads on the outer surface of the catheter hub 14 and theopposing member 204 extends into the proximal opening of the catheterhub 14. In order to remove the catch 190 from the catheter hub 14, theouter sleeve 178 of the needle tip shield 176 must be raised so that thecatch 190 can slide over the Luer threads. Raising the needle tip shield176 relative to the catheter hub 14, however, is initially prevented bythe opposing member 204 extending into the catheter hub 14.

As the needle 12 is withdrawn from the catheter hub 14, the tip of theneedle 12 clears the first and second hooks 212, 214, as illustrated inFIG. 37, causing the first and second arms 208, 210 to close and thefirst and second hooks 212, 214 to surround the tip of the needle 12. Assuch, the clip 182 is in a closed position where the distal tip of theneedle 12 is blocked. This needle protection mechanism, via the clip182, operates passively (automatically) when the needle 12 is removedfrom the catheter hub 14 because user actuation is not required toinitiate needle protection.

As the needle 12 is pulled further, the shaft of the needle slidesthrough the needle tip shield 176 until a deformation, for example acrimp or protrusion 250 formed near the distal end of the needle 12 toincrease its diameter in at least one direction, engages the clip base206. The opening in the clip base 206 is sized to interact with thedeformation such that the needle shaft passes through, but not thedeformation. Accordingly, a sharp distal tip area, which includes thesharp distal tip and the deformation of the needle 12, for example, isenclosed by the clip 182.

Further movement of the needle 12 results in the inner sleeve 180 beingdrawn further into the outer sleeve 178, removing the opposing member204 from the catheter hub 14. When the opposing member 204 is withdrawnfrom the catheter hub 14, the catch 190 may be removed from the Luerthread protrusion and the needle tip shield 176, needle 12, and needlehub 16 separated from the catheter 10.

FIG. 35 shows the arm 198 and tab 200 of the inner sleeve 180 positionedin the slot 188 of the outer sleeve 178. After the tip of the needle 12passes the first and second hooks 212, 214 and the first and second arms208, 210 move into a closed orientation, the tab 200 can engage the slot188 to resist separation of the inner sleeve 180 and the outer sleeve178 and possible exposure of the needle 12.

FIG. 36 shows the first and second tabs 216, 218 engaging a firstshoulder 220 and a second shoulder 222 on the outer sleeve. The tabs220, 222 help prevent the clip 182 and the inner sleeve 180 fromunintentionally sliding into the outer sleeve 178, for example duringshipping. The needle 12 biases the first and second arms 208, 210 intoan open position so that the tabs 216, 218 engage the outer sleeve 178.

Any of the various exemplary embodiments discussed herein may include anantimicrobial system, such that one or more antimicrobial agents orcoatings may be incorporated or applied to any of the components of thecatheter discussed herein. For example, the spring may be coated with aUV curable antimicrobial adhesive coating. The coating may be appliedspraying, batch tumbling, or during formation of the spring windings. Asuitable coating is described in U.S. Pat. No. 8,691,887, the disclosureof which is incorporated by reference. Antimicrobial agents suitable foruse in this is type of application included, chlorhexidine gluconate,chlorhexidine diacetate, chloroxylenol, triclosan, hexetidine, and maybe included in a actuator lubricant applied to assist in easypenetration and opening of the septum, and return of the actuator to theclosed position after Luer connector disengagement.

FIG. 38 illustrates an exemplary embodiment of an actuator 54. Theactuator 54 can be used in any of the embodiments disclosed herein. Theactuator 54 includes a nose 58 that reduces friction when the actuator54 penetrates into a septum 38 of a catheter hub assembly. The actuator54 further includes openings 55 that extend through the actuator 54 in adirection perpendicular to a centerline of the actuator 54. For example,the actuator 54 can include two rectangular shaped openings 55, althoughmore or less are contemplated.

The actuator 54 also includes a plurality of grooves 57 that extendaxially along the distal portion of an outer surface of the actuator 54in a plane parallel to the centerline of the actuator 54. For example,four grooves 57, substantially radially equidistant from each other, canbe present along an external surface of the distal portion of theactuator 54, although more or less grooves 57 are contemplated. Thegrooves 57 can be of varying depths into the actuator 54. The grooves 57are different from the openings 55 because the grooves 57 do not extendcompletely through the thickness of the actuator 54.

The openings 55 and the grooves 57 advantageously provide increased areafor the fluid to move inside the catheter hub assembly. The increasedarea advantageously allows for fluid flushing and to prevent coagulationof fluid in the proximal and distal ends of the septum. Additionally,the openings 55 and the plurality of grooves 57 advantageously minimizethe stagnation of fluid and allow for greater mixing. The grooves 57further prevent the septum from sealing on an outside surface of theactuator during operation. By not forming a sealing interface, the fluidis permitted to leak through the septum via the grooves 57 and provideadditional flushing.

FIG. 39A illustrates the actuator 54 of FIG. 38 in the catheter hubassembly. Similar to the embodiments described above, the catheter hubassembly further includes a catheter hub 14, a septum 38 and a biasingmember 56. As illustrated, the openings 55 and the grooves 57 of theactuator 54 provide more area for fluid flow inside the catheter hub 14,thus achieving the advantages described above.

FIGS. 39B and 39C illustrate the catheter hub assembly when the biasingmember 56 is compressed and the actuator 54 penetrates the septum 38.The catheter hub assembly may be configured such that the openings 55and/or the grooves 57 of the actuator 54 optionally penetrate the septum38. In this embodiment, the openings 55 in the actuator 54 do notpenetrate the septum 38. However, the grooves 57 in the actuator 54penetrate the septum 38. This configuration allows for increased fluidflow from the proximal end to the distal end of the septum 38 throughthe grooves 57, in addition to the advantages described above. Afteroperation of the catheter assembly is complete, the actuator 54 isretracted from the septum 38 via the force exerted by the biasing member56. The catheter assembly is configured for multiple uses upondepression of the actuator 54. The features described in thisembodiment, such as the actuator, can be used in combination with thefeatures described throughout this application.

FIG. 40A illustrates another embodiment of an actuator 164 in a catheterhub assembly. The catheter hub assembly includes a catheter hub 162having a side port 168. The side port 168 provides secondary access tothe fluid flow in the catheter hub 162. The intersection of the mainbore of the catheter hub 162 and the side port 168 includes a sleeve172. The sleeve 172 provides selective fluid communication between theside port 168 and the catheter hub 162. Specifically, when sufficientfluid pressure is applied through the side port 168, the sleeve 172compresses. The compression of the sleeve 172 allows for fluid to enterthe catheter hub 162. The catheter hub assembly further includes aseptum 170 and a biasing member 166 that provides tension to theactuator 164.

The actuator 164 includes a plurality of openings 165 that extendthrough the actuator 164 in a similar manner as described above. Theactuator 164 includes two rows of four openings 165 having differentsizes and spacing, although various quantities, sizes and spacing of theopenings 165 are contemplated. As illustrated, the openings 165 providemore area for fluid flow inside the catheter hub 14, thus achievingsimilar advantages described above with respect to FIGS. 38-39C.

FIGS. 40B and 40C illustrate the catheter hub assembly when the actuator164 penetrates the septum 170 and compresses the biasing member 166. Thecatheter hub assembly is configured such that the openings 165 of theactuator 164 optionally penetrate the septum 170. In this embodiment,the openings 165 in the actuator 164 do not penetrate the septum 170.This configuration allows for increased fluid flow between the side port168 and the catheter hub 162 at the proximal end of the septum 38, inaddition to the advantages described above. If the openings 165 in theactuator 164 penetrate the septum 170, increased mixing of fluid wouldalso take place at a distal end of the septum 38.

When operation of the catheter assembly is complete, the actuator 164 isretracted from the septum 170 via the force exerted by the biasingmember 166. The catheter assembly is configured for multiple uses upondepression of the actuator 164. The features described in thisembodiment, such as the actuator, can be used in combination with thefeatures described throughout this application.

FIG. 41 illustrates a cross sectional view of another exemplaryembodiment of a catheter assembly 300 with a different type of needleprotection mechanism, in this case one that houses the entire needlewithin a protective tube or barrel, rather than shielding only theneedle tip. The catheter assembly 300 employs active (rather thanpassive or automatic) needle protection because user activation, viadepression of an activation button 308, is required to initiate needleprotection. However, both active and passive needle protection arewithin the scope of the present invention.

Operation of the catheter assembly 300 is described as follows. Thecatheter 302 and the needle 304 are inserted into a vein of a patient.When the needle 304 and catheter 302 are securely disposed, theactivation button 308 is depressed. Upon depression of the activationbutton 308, as illustrated in FIG. 42, an inner needle hub or housing312 is disengaged from a wall (not shown) of the activation button 308.The needle 304 then retracts into a catheter hub 306. A spring 310surrounding the inner needle housing 312 is released by the activationbutton 308 which causes the inner needle housing 312 to travel to theopposite end of the outer needle housing 314. Thus, the needle 304 isnow in a retracted position where the complete needle 304 (including itssharp distal tip) is retained in the outer needle housing 314. The innerneedle housing 312 holding the needle 304 is retained in the outerneedle housing 314 via the force exerted by the spring 310. Accordingly,the combination of the inner needle housing 312, the outer needlehousing 314 and the spring 310 is an exemplary needle protection member.

More information regarding the active needle protection mechanism usedin this embodiment can be found in U.S. Pat. Nos. 4,747,831, 5,501,675,5,575,777, 5,700,250, 5,702,367, 5,830,190, 5,911,705, 8,361,038,8,388,583, 8,469,928, 8,864,715, and 8,932,259, the contents of whichare hereby incorporated by reference. The features described in thisembodiment, including the active needle protection features, can be usedin combination with the catheter assemblies described throughout thisapplication.

FIG. 43 illustrates a cross sectional view of another exemplaryembodiment of a catheter assembly 400 with a different type of needleprotection mechanism, in this case one like that of FIGS. 27-37 thatshields only the needle tip. The needle protection mechanism disclosedin the catheter assembly 400 operates passively (automatically) when theneedle 402 is removed from the catheter hub 406 because user actuationis not required to initiate needle protection. Operation of the catheterassembly 400 is described as follows. The catheter 404 and the needle402 are inserted into a vein of a patient. When the needle 402 andcatheter 404 are securely disposed, the needle 402 is withdrawn by auser.

The needle 402 is withdrawn from the catheter 404 when the user pullsthe outer needle housing or hub 414. The needle 402 subsequentlyretracts into the catheter hub 406 and a sharp distal tip of the needle402 ultimately enters into the inner needle housing 408. Prior to thedistal tip of the needle 402 entering into the inner needle housing 408,the needle 402 contacts and biases a longitudinal metal clip 412 into anopen position. The longitudinal clip 412 can be, for example, a leafspring that extends and compresses in a longitudinal direction. When thedistal tip of the needle 402 sufficiently enters into the inner needlehousing 408, as illustrated in FIG. 44, the clip 412 extends into theinner needle housing 408 towards a centerline of the needle 402.Accordingly, the clip 412 is no longer biased and enters into a closedposition where the distal tip of the needle 402 is blocked.

The needle 402 further includes a deformation 403 adjacent to its distaltip. In at least one direction, the diameter of the deformation 403 isgreater than the diameter of the remainder of the needle 402. Thedeformation 403 prevents the needle 402 from exiting the inner needlehousing 408 during retraction of the needle 402. Specifically, when thedistal tip of the needle 402 is in the inner needle housing 408, thedeformation 403 contacts a rear wall of the inner needle housing 408 andprevents the needle 402 from exiting the inner needle housing 408. Thus,the distal tip and the deformation 403 of the needle 402 are enclosed inthe inner needle housing 408. The clip 412, needle 402, inner needlehousing 408 and outer needle housing 414 are an exemplary needleprotection member.

As illustrated in FIG. 45, when the user continues to pull the outerneedle housing 414, the inner needle housing 408 and the catheter hub406 disengage and separate. Specifically, a boss 410 of the inner needlehousing 408 disengages from a bore in the catheter hub 406.

After the needle 402 is used, the inner needle housing 408 enclosing thetip of the needle 402 and the outer needle housing 414 are discarded.The catheter hub assembly can be subsequently used. Specifically, theuser can engage a Luer connector 416 with the catheter hub 406 to causethe actuator to open or penetrate the septum and establish fluidcommunication.

More information regarding the needle tip protection mechanism used inthis embodiment can be found in U.S. Pat. Nos. 5,215,528 and 5,558,651,the contents of which are hereby incorporated by reference. The featuresdescribed in this embodiment, including the passive needle protection,can be used in combination with the catheters described throughout thisapplication.

FIG. 46 illustrates a cross sectional view of another exemplaryembodiment of a catheter assembly 500 with a needle tip shield. Theneedle protection mechanism disclosed in the catheter assembly 500operates passively (automatically) when the needle 512 is removed fromthe catheter hub 514 because user actuation is not required to initiateneedle protection. Operation of the catheter assembly 500 is describedas follows. During operation, a needle 512 extends through an actuator528 that pierces a septum 526 in a catheter hub 514, as similarlydescribed in the embodiments above. A V-clip 540, located in a needletip shield 520, is biased by the needle 512 into an open position (theV-clip 540 is collapsed) to allow the needle 512 to pass beyond theV-clip 540. The V-clip 540 comprises a resilient metal clip. Afteroperation of the catheter assembly 500, the biasing member 530 retractsthe actuator 528 into the catheter hub 514.

FIG. 47 illustrates a cross sectional view of the catheter assembly 500when the needle 512 is in a retracted position. When a distal tip of theneedle 512 enters into the needle tip shield 520 and is positioned onthe proximal end of the V-clip 540, the V-clip 540 is no longer biased.Rather, the V-clip 540 expands in the needle tip shield 520 into aclosed position (the V-clip is expanded) to prevent the needle 512 fromtraveling beyond the V-clip 540. The expansion of the V-clip 540 in theneedle tip shield 520 forms one or more barriers (as described below)that prevent the distal tip of the needle 512 from exiting the needletip shield 520.

The needle tip shield 520 includes a metal washer 542 and the needle 512includes a deformation 596 adjacent to the distal tip of the needle 512.In at least one radial direction, the diameter of the deformation isgreater than the diameter of the remainder of the needle 512. In atleast one radial direction, the diameter of the deformation 596 isbigger than a through-hole in the washer 542 where the needle 512travels. Thus, the deformation 596 prevents the needle 512 from exitingthe washer 542 during needle 512 retraction. Accordingly, when theneedle 512 is in the retracted position, the distal tip of the needle512 and the deformation 596 are enclosed via the washer 542 and thebarrier of the V-clip 540.

FIG. 48 illustrates a bottom plan view of the catheter hub assembly andthe needle hub assembly when the needle is retracted. The catheter hub514 includes a collar 534 having a collar opening 536 and Luer threads532. When the needle 512 biases the V-clip 540 into an open position asdescribed above, a latch 584 that is connected to a foot 582 of theV-clip 540 engages the collar 534. The V-clip 540 being engaged with thecollar 534 keeps the catheter hub 514 and the needle tip shield 520connected.

On the other hand, when the needle 512 is in the retracted position andno longer biases the V-clip 540, the V-clip 540 moves to the closedposition. In the closed position, the latch 584 and the foot 582 of theV-clip 540 move into axial alignment with the collar opening 536. Thecollar opening 536 thus allows the catheter hub 514 to disengage fromthe needle tip shield 520.

Additionally, when the V-clip 540 moves to the closed position, abarrier 578 in the V-clip 540 prevents the distal tip of the needle 512from exiting the needle tip shield 520. Preferably, the barrier 578includes two barriers although more or less are contemplated. Thecombination of the V-clip 540 and the washer 542 is an exemplary needleprotection member.

The V-clip 540 further includes an outer wall 570 and a spade 566 thatare configured to attach the V-clip 540 to an outer wall of the needletip shield 520. The outer wall of the needle tip shield 520 includesprojections 589 that secure the V-clip 540 by creating friction betweenthe V-clip 540 and the needle tip shield 520. This configurationadvantageously secures the V-clip 540 to the needle tip shield 520 andavoids the use of an outer housing for mounting. Accordingly, the widthof the needle tip shield 520 is advantageously reduced.

Upon separation of the catheter hub assembly and the needle tip shield520, the catheter hub assembly can be subsequently used as a multi-useblood control apparatus.

Specifically, the actuator 528 can be engaged multiple times through theuse of the Luer threads 532 in a similar manner as described in theabove embodiments.

More information regarding the needle tip protection mechanism used inthis embodiment can be found in U.S. Pat. Nos. 6,749,588, 7,604,616 andU.S. Patent Application Publication No. 2014/0364809, the contents ofwhich are hereby incorporated by reference. The features described inthis embodiment, including the passive needle protection features, canbe used in combination with the features described throughout thisapplication.

Needle protection members other than those disclosed herein may be usedin the present invention. These may be needle tip shields as exemplifiedby the embodiments of FIGS. 27-37, 43-45, and 46-48, needle-enclosingtubes or barrels as exemplified by the embodiment of FIGS. 41-42, orother arrangements. They may operate passively (automatically) when theneedle is removed from the catheter hub as in the embodiments of FIGS.27-37, 43-45 and 46-48, or they may require active user actuation as inthe embodiments of FIGS. 41-42.

FIGS. 49-51 illustrate various exemplary embodiments of blood flashbackfeatures in the catheter assembly. Flashback is the visibility of bloodthat confirms the entry of the needle tip into the vein. Primaryflashback 600 is seen through the catheter tubing as blood travels intothe open distal end of the hollow needle 612, out a notch or opening 602in the needle 612 near the needle tip, and up through the internalannular space between the needle 612 and the inside of the cathetertubing. The secondary flashback 604 is seen in the needle hub/grip whenit comes out of the back of the needle 612 and enters a flash chamber inthe needle hub/grip. Air is vented by the plug in the back of the needlehub/grip by a porous membrane or micro grooves. Tertiary flashback 606is visible in the catheter hub 614 when the blood from the primaryflashback 600 flows into it and stops at the blood control septum. Airis vented by the micro grooves in the periphery of the blood controlseptum. The features described in these embodiments, including the bloodflashback features, can be used in combination with the featuresdescribed throughout this application.

In another embodiment similar to the embodiment illustrated in FIGS.3-8, the assembly 10 does not include a return member 56. Rather, asdescribed earlier, the flaps defined by the slits 42 of the resilientseptum 38 act as the return member 56. Prior to operation, the actuator44 is in a free state and does not contact the septum 38 (first positionof the actuator 44). In operation, the septum 38 is in an opened statewhere the actuator 44 (second position of the actuator 44) contacts orpushes against the slits 42 of the septum 38. The opened state of theseptum 38 permits fluid communication. In the opened state of the septum38, the actuator 44 does not extend through the septum 38. In otherwords, the actuator 44 does not penetrate the septum 38. As a result,the resilient flaps defined by the open slits 42 of the septum 38 causethe actuator 44 to retract to the first position when operation iscomplete and upon removal of the axial pressure on the actuator 44.

In another embodiment, as illustrated in FIGS. 52-55, the valveactuators 744 function in a similar manner to the valve actuators of thecatheter assembly as described in the embodiments of FIG. 3-8. However,for the reasons described below, the valve actuators 744 of thefollowing embodiments improve the flushing capability of the catheterassembly during a saline flush.

Similar to the embodiment of FIGS. 3-8, the valve actuators 744 includea shaft portion 750, a diameter reduction region 752 and a matingportion 754. The valve actuators 744 may be approximately 0.529 inchesin length. The shaft portion 750 is configured to penetrate a septum ofa catheter assembly. Specifically, the shaft portion 750 includes adistal opening 746b that provides an entrance into a hollow internalpassage 746 a that extends through a length of the valve actuator 744.When the valve actuator 744 penetrates the septum, fluid, such as bloodor saline, travels through the hollow internal passage 746 a . The valveactuator 744 also includes a plurality of openings 746 c that provide apassageway for the fluid to exit the hollow internal passage 746 a.

The mating portion 754 is disposed at a distal end of the valve actuator744. An outer diameter of the mating portion 754 may be approximately0.138 inches. The outer diameter of the mating portion 754 is largerthan an outer diameter of the shaft portion 750 so that the matingportion 754 can engage and disengage with a Luer connector.

The diameter reduction region 752 is an inclined member disposed near aproximal end of an inner diameter of the valve actuator 744. Thediameter reduction region 752 is disposed between the shaft portion 750and the mating portion 754 to connect the shaft portion 750 and matingportion 754 and to provide a continuous outer surface of the valveactuator 744. The diameter reduction region 752 includes a plurality ofprotrusions 758 on an outer diameter as illustrated in FIGS. 52-57, aswell as on an inner diameter as illustrated in FIG. 58. The protrusions758 advantageously aid in assembling a spring and securing the spring inthe catheter assembly during operation.

The diameter reduction region 752 further includes a plurality ofwindows 756. As illustrated in FIGS. 3-8, the windows can extend thefull length of the diameter reduction region of the valve actuator. In avalve actuator 744 having a length of approximately 0.529 inches and amaximum outside diameter of approximately 0.138 inches, the full length(or height) of the diameter reduction region of FIGS. 3-8 can be0.035-0.040 inches, for example. However, in FIGS. 52-55 the windows 756extend only a portion of the diameter reduction region 752.

Specifically, FIGS. 52-55 illustrate that for an actuator of the overallsize mentioned, the windows 756 can extend approximately 0.005 inches,0.010 inches, 0.015 inches and 0.020 inches from a distal end of thediameter reduction region 752, respectively. Other embodiments includewindows 756 at any length less than the full length of the diameterreduction region 752. Alternately, the windows 756 can extendapproximately ½ or ⅓ of the length of the diameter reduction region 752.FIGS. 56 and 57 illustrate windows 756 adjacent to a distal end of thediameter reduction region 752 but outside the diameter reduction region752. The windows 756 of FIGS. 56 and 57 are in the mating portion 754 ofthe valve actuator 756. The windows 756 of FIGS. 56 and 57 can extend ata length of approximately 0.010 inches and 0.020 inches, respectively.Advantages of the windows 756 are provided below.

During use, the valve actuator 756 is typically flushed with saline, forexample, to remove any remaining blood or fluid. However, blood or fluiddeposits can remain even after the saline flush. The windows 756 arereduced in size and placed at a proximal end of the diameter reductionregion 752 to advantageously improve saline flushing.

Specifically, the size (length or height) of the windows 756 increasesthe velocity of the saline flow. The saline flow 748 of FIG. 54A isrepresentative of each of the windows 756 of FIGS. 52-55. As illustratedin FIG. 54A, the fluid flushing velocity of the saline flows almostentirely in a radial direction when exiting the windows 756. This isbecause the size of the windows 756 is smaller than the windows of thevalve actuators in FIGS. 3-8. The size of the windows 756 causes thefluid that is traveling through the internal passage 746 a in alongitudinal direction (axial direction) to shift into a perpendiculardirection (radial direction) to exit the valve actuator 744. For anactuator of the overall size mentioned, the preferred optimal size(length or height) is approximately 0.0125±0.005 inches. The closer thesize of the windows 756 to the preferred size, the more radial thedirection of flow of fluid will exit out of the windows 756. The radialflow at a higher velocity will optimize flushing performance.

When compared to the embodiments of FIGS. 52-58, the flushing fluidvelocity traveling through the windows of the valve actuators in FIGS.3-8 has a higher axial component and travels at a lower velocity becauseof the large window size. As a result, a small section of reducedflushing can remain near a corner between the inner diameter of theadapter and the proximal end of the flushing window.

The placement of the windows 756 at the distal end of the diameterreduction region 752 improves the speed and direction of flow. Thewindows 756 outside the diameter reduction portion 752 cause the flow offluid in the internal passage 746 a to change direction more abruptlycompared to the windows in the valve actuators of FIGS. 3-8. This isbecause the fluid flowing through the internal passage 746 a travelsshorter by the time the flow reaches the windows 756. Thus, the windows756 outside the proximal end of the diameter reduction portion 750forces flow to change into more of a radial direction when exiting thewindows 756.

The fluid traveling through the windows 756 in the diameter reductionregion 752 responds similarly. In these embodiments, the distance of thewindows 756 from the centerline of the valve actuator 744 is variablebetween the distal end and the proximal end of the diameter reductionregion 752. This variable flow travel length slightly alters theflushing performance of the windows 756. As described above, for anactuator of the overall size mentioned, the optimal window size (lengthor height) is approximately 0.0125±0.005 inches. The combination of theradial flow direction and the increased velocity advantageously enhancesflushing.

FIGS. 59 and 60 are graphical illustrations of the improved flushingperformance of the valve actuator. FIG. 59 represents the valve actuatorwith the windows of FIGS. 3-8 and FIG. 60 represents the valve actuatorwith the windows 756 of FIG. 53. The hash lines identified by a numberrepresent the amount of blood remaining in the catheter hub after asaline flush. The remaining blood is measured by a ratio of blood massto 3 milliliters of saline where 760 has a ratio of 1.0, 762 has a ratioof 0.9, 764 has a ratio of 0.8, 766 has a ratio of 0.7 and 764 has aratio 0. As indicated in the window section of FIGS. 59 and 60, theamount of blood remaining in the reduced window design of FIG. 60 issignificantly less than the amount of blood remaining in the normalwindow design of FIG. 59.

FIG. 61 shows another illustration of the amount of blood remainingafter a 3 milliliter saline flush. Data points show the amount of bloodremaining after a saline flush in the various sizes of the windows 756in the valve actuators 744 of FIGS. 52-55 and in the window of the valveactuator of FIGS. 3-8. Specifically, the amount of blood remaining isapproximately 2.2% with the 0.0125 inch window height. The amount ofblood remaining is approximately 4.3% with the 0.0375 inch window heightof FIGS. 3-8. Thus, as illustrated, the fluid flushing performance isapproximately 50% improved when the window is approximately 0.0125inches when compared to the windows in the valve actuators of FIGS. 3-8.

FIGS. 62-65 illustrate an alternate embodiment of the catheter assembly810 with various components that function in a similar manner to theembodiments described above. In particular, a needle hub 816 operates ina similar manner as the embodiment of FIGS. 46-48. The catheter hub 814operates in a similar manner as the embodiment of FIGS. 4-8 except forthe differences detailed below.

The needle and catheter tubing of the catheter assembly 810 are enclosedby a needle cover 878 when not in use. The needle cover 878 is removedto begin operation of the catheter assembly 810. The catheter assembly810 also includes a flow control plug 820 that is similarly described inFIG. 51. Specifically, the plug 820 includes a porous membrane or microgrooves being disposed at a proximal end of the needle hub 816 to ventair while containing blood.

FIG. 63 illustrates the catheter hub 814 and the needle hub 816 of thecatheter assembly 810. Specifically, the catheter hub 814 includes ametal wedge 834 made of, for example, 302, 304 or 305 stainless steel inan annealed state. Alternately, the metal wedge 834 can be 302 or 304stainless steel in the annealed or close to annealed state. 302 and 304stainless steels have a very low magnetic susceptibility in the annealedstate, which is advantageous when the catheter assembly is left in placeon a patient during a magnetic resonance imaging (MRI) procedure.

FIG. 64 illustrates the catheter hub 814 and FIG. 65 illustrates a valveactuator 844 of the catheter hub 814 prior to operation. Specifically,the catheter hub 814 includes an inner diameter 815, as well as anundercut 813. The inner diameter 815 is larger than the undercut 813.The undercut 813 is used to secure a spring 856, as further describedbelow.

The catheter hub 814 also includes a septum 838. The septum 838 issecured via an interference fit to the inner diameter 815 of thecatheter hub 814 to ensure proper operation of the septum 838. Theseptum 838 contacts an inner wall of the catheter hub 814 for properpositioning. The septum 838 passes the undercut 813 when assembled froma proximal end of the catheter hub 814.

The valve actuator 844 is configured to penetrate the septum 838 duringoperation of the catheter assembly 810. The spring 856 is compressedwhen the valve actuator 844 penetrates the septum 838. Subsequently, thespring 856 retracts the valve actuator 844 after piercing the septum838. The spring 856 includes center coils 857 and two or more end coils858. The end coils 858 have a greater outer diameter than the centercoils 857.

Tests show that the material of the metal wedge 834 does not causemagnetic problems during MRI procedures, but this is not necessarily thecase for the spring 856. Either 302 or 304 stainless steel is theconventional material used for springs because of its higher carboncontent and ease of manufacturability. However, the catheter assemblyincluding the spring composed of 302 or 304 stainless steel has veryhigh magnetic properties when hardened to the level that a springrequires. Specifically, the metal of the spring must be cold worked tospring temper in order to have the higher shear strength, whichconsequentially makes the metal more magnetically susceptible.

Accordingly, springs composed of 302 or 304 stainless steel in thecatheter assembly may not be compatible for use during magneticresonance imaging (MRI) procedures. This is because the magnets of anMRI device can cause susceptible metals in the catheter assembly topull, twist and heat up. As a result, a catheter assembly with springscomposed of 302 or 304 stainless steel should be removed from thepatient prior to MRI procedures.

316 stainless steel is not commonly used as a spring material because ofits low strength, high cost and difficulty in processing. However, 316stainless steel is the preferred material for the spring 856 andadvantageously improves in strength as the temper of the materialchanges. In this embodiment, the temper of 316 stainless steel isincreased to satisfy an ASTM F138-08 material strength standard forstainless steel surgical implant devices. Preferably, the strengthrequirement for the spring 856 exceeds what is specified in ASTM F138.

As the temper of 316 stainless steel increases, the magnetic attractionalso increases. However, the magnetic properties of 316 stainless steelare less than 302 or 304 stainless steel because of the lower carboncontent. Specifically, the composition of the 316 series stainless steelor their equivalents, especially the chromium and nickel content and theratio of Cr/Ni content in these alloys, helps the austenite phase remainstable through the cold working process and resist transformation tomartensite. The low carbon content of an 1′ grade 316 stainless steelalso aids in alloy stability. Thus, when 316 stainless steel achievesspring temper, the spring 856 in the catheter assembly 810 is compatiblefor use during MRI procedures.

In particular, the spring 856 is advantageously made of 316 stainlesssteel that is cold worked to a spring temper. Other preferred materialsof the spring 856 include 316L stainless steel, 316 LVM stainless steel(bare wire with no nickel coating having a 240 ksi minimum tensilestrength), titanium, beryllium, copper, magnesium and magnesium alloyssuch as Elgiloy. Alternatively, or in addition, the spring 856 is platedwith a diamagnetic material, such as palladium, to reach the desiredmagnetic permeability. The spring 856 can be magnetically susceptiblebut plated with a diamagnetic material to substantially cancel out theoverall magnetism of the material. Thus, the diamagnetic material canhelp achieve a zero net attraction force of the metal.

These material and process selections allow the spring 856 in thecatheter assembly 810 to achieve a magnetic relative permeability thatis less than 2.0 and preferably less than 1.1. The magnetic relativepermeability is a dimensionless value that is commonly understood by oneof ordinary skill in the art. The material and associated processingselection for the spring 856 advantageously allows the catheter assembly810 to remain attached to the patient during MRI procedures. In otherwords, the correct alloys and tempers of metals are used in the catheterassembly 810 to keep magnetic susceptibility low enough so that there isno compatibility concern with the catheter assembly 810 during MRIprocedures.

During assembly, one of the end coils 858 of the spring 856 travels pastthe undercut 813 and is snapped into place. Specifically, the end coil858 is movably captured between the septum 838 and the undercut 813. Theend coils 858 of the spring 856 advantageously do not have to bedisposed at a precise location. The outer diameter of the end coils 858is greater than the diameter of the undercut 813 to movably retain thespring 856. Thus, the spring 856 and catheter hub 814 advantageouslyprevent the inadvertent removal of the valve actuator 844. Also, theimproved assembly advantageously causes less variation to the functionof the catheter assembly 810.

An outer diameter of the center coils 857 is smaller than the diameterof the undercut 813. This advantageously prevents interference andallows the spring 856 to move axially in the catheter hub 814 by alimited amount, until a Luer connector is attached.

A clearance fit is present between the inner diameter 815 of thecatheter hub 814 and the outer diameter of the end coils 858 of thespring 856. A clearance fit advantageously facilitates assembly andoperation of the spring 856. Specifically, once the end coils 858 passthe undercut 813 during assembly, the spring 856 is properly located.The other end coil 858 is immovably fixed to the valve actuator 844.Thus, the spring 856 and the valve actuator 844 can axially move “orfloat” (within limits) inside the catheter hub 814 when no Luerconnector is present. The actuator does not contact the inner diameter815 of the catheter hub 814.

When an interference fit is present between the spring and the innerdiameter of the catheter hub as described in the embodiment of FIGS.3-8, it can be difficult to place the spring in the correct position.Specifically, it can be difficult to set the exact position of thespring because of the length of the inner diameter in the catheter hub.Also, the shoulder that the septum rests on is deep inside the length ofthe inner diameter of the catheter hub.

Moreover, an interference fit requires very tight tolerances on theouter diameter of the spring, as well as the inner diameter of thecatheter hub. If the interference fit is too severe, the life of thespring may be compromised. If the interface between the spring and theinner diameter of the catheter hub becomes loose, then the spring andthe valve actuator may be inadvertently removed.

The interference fit can also present problems in operation because theseptum may move with the spring during retraction. This is because theinterference fit between the spring and the inner diameter of thecatheter hub may create a jam where the septum moves with the spring.The high forces in an interference fit can overcome the frictionalforces of the septum and cause the septum to move with the spring.Additionally, the interference fit can cause undue pressure on the valveactuator 844 during retraction. Also, if the spring 856 is compressedtoo far distally such that the septum 838 is compressed, an interferencefit may not allow the septum 838 to retract or relax. As a result, theseptum 838 may leak over time due to the excessive and continuouscompression.

On the other hand, when a clearance fit is present between the spring856 and the inner diameter 815 of the catheter hub 814, the spring 856can move axially when no Luer connector is present and can applypressure to a proximal face of the septum 838 only when a Luer connectoris inserted. Thus, the combination of the clearance fit and the undercut813 advantageously improves the operation, the ability to position thespring 856, and the manufacturability of the catheter assembly.

According to another embodiment, as illustrated in FIGS. 66-68, a valveactuator 900 with a single-stepped distal tip includes a side opening902, a distal end 904, a distal end opening 905, a step 906, radii 908,and an outer diameter 910. The openings 902, 905 provide for fluidflushing and flow through the valve actuator 900 when engaged to aseptum in a catheter hub. The openings 902, 905 operate in a similarmanner described above in previous embodiments.

The step 906 is disposed between the distal end 904 and the outerdiameter 910 of the valve actuator 900. Since the valve actuator 900 isinjection molded, no sharp edges are formed on its outer surface.Instead, radii 908 are disposed on either end surface of the step 906.Specifically, a radius 908 is disposed at the interface of the step 906and the distal end 904, as well as at the interface between the step 906and the outer diameter 910. The step 906 at the distal end 904 of thevalve actuator 900 replaces the taper at the distal end of the valveactuators of previous embodiments. The radii 908 advantageously allowfor ease of manufacturability during injection molding.

FIGS. 69-71 illustrate a valve actuator 950 with a double-stepped distaltip according to another embodiment. In this embodiment, the valveactuator 950 includes an opening 952, a distal end 954, a distal endopening 955, radii 958, and an outer diameter 960 in a similar manner asdescribed in the embodiment of FIGS. 66-68. However, the valve actuator950 has two steps 956 between the outer diameter 960 and the distal end954. The two steps 956 have two different diameters with appropriateradii 958 on each end surface. Likewise, the radii 908 advantageouslyallow for ease of manufacturability during injection molding.

The foregoing detailed description of the certain exemplary embodimentshas been provided for the purpose of explaining the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications as are suited to the particular use contemplated.This description is not necessarily intended to be exhaustive or tolimit the invention to the precise embodiments disclosed. Any of theembodiments and/or elements disclosed herein may be combined with oneanother to form various additional embodiments not specificallydisclosed. Accordingly, additional embodiments are possible and areintended to be encompassed within this specification and the scope ofthe invention. The specification describes specific examples toaccomplish a more general goal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,”“lower,” “upwardly,” “downwardly,” and other orientational descriptorsare intended to facilitate the description of the exemplary embodimentsof the present invention, and are not intended to limit the structure ofthe exemplary embodiments of the present invention to any particularposition or orientation. Terms of degree, such as “substantially” or“approximately” are understood by those of ordinary skill to refer toreasonable ranges outside of the given value, for example, generaltolerances associated with manufacturing, assembly, and use of thedescribed embodiments.

What is claimed is:
 1. A catheter assembly comprising: a catheter; aneedle including a distal tip and disposed within the catheter; acatheter hub connected to the catheter having the needle passingtherethrough, the catheter hub including: an inner diameter; a valvethat selectively permits or blocks a flow of fluid through the catheter;a valve actuator that moves between a first position and a secondposition; and a spring that returns the valve actuator from the secondposition to the first position, wherein a clearance fit is providedbetween the spring and the inner diameter.
 2. The catheter assembly ofclaim 1, wherein the inner diameter of the catheter hub includes anundercut, and the spring is retained by the undercut.
 3. The catheterassembly of claim 2, wherein an outer diameter of a distal portion ofthe spring is greater than an inner diameter of the undercut.
 4. Thecatheter assembly of claim 1, wherein the spring comprises a coil springthat surrounds the valve actuator.
 5. The catheter assembly of claim 1,wherein the spring includes center coils and two or more end coils, andan outer diameter of the end coils is greater than an outer diameter ofthe two or more center coils.
 6. The catheter assembly of claim 1,wherein an interference fit is provided between one of the end coils andthe valve actuator.
 7. The catheter assembly of claim 1, wherein aclearance fit is provided between center coils and an undercut of thecatheter hub.
 8. The catheter assembly of claim 1, wherein aninterference fit retains the valve to the inner diameter of the catheterhub.
 9. The catheter assembly of claim 1, wherein the valve actuatordoes not contact the inner diameter of the catheter hub.
 10. Thecatheter assembly of claim 1, wherein the spring comprises a metallicmember with a magnetic relative permeability less than 2.0.
 11. Acatheter assembly comprising: a catheter; a needle having a distal tipand disposed within the catheter; a catheter hub connected to thecatheter having the needle passing therethrough, the catheter hubincluding: a valve that selectively permits or blocks a flow of fluidthrough the catheter; a valve actuator that moves between a firstposition and a second position; and a return member that returns thevalve actuator from the second position to the first position; and aneedle protection member that encloses the distal tip of the needle,wherein the return member comprises a metallic member with a magneticrelative permeability less than 2.0.
 12. The catheter assembly of claim11, wherein the return member comprises a spring.
 13. The catheterassembly of claim 11, wherein the return member comprises a materialselected from the group consisting of 316L stainless steel, 316 Lvmstainless steel, titanium, beryllium, copper, magnesium and magnesiumalloys.
 14. The catheter assembly of claim 11, wherein the return membercomprises a magnesium alloy or Elgiloy.
 15. The catheter assembly ofclaim 11, wherein the magnetic relative permeability is less than 2.0.16. The catheter assembly of claim 11, wherein the magnetic relativepermeability is less than 1.1.
 17. The catheter assembly of claim 11,wherein the return member comprises a plating including a diamagneticmaterial.
 18. The catheter assembly of claim 17, wherein the diamagneticmaterial comprises palladium.
 19. The catheter assembly of claim 11,wherein the catheter assembly is configured to remain attached to apatient during an MRI procedure.